ctDNA in Cancer Treatment and Clinical Care (Speaker Bios)
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Pedro C. Barata, M.D. M.Sc.
Associate Professor of Medicine, Case Western Reserve University, Director of Clinical Genitourinary Medical Oncology, University Hospitals Seidman Cancer CenterDr. Barata is an Associate Professor of Medicine at Case Western University. He is a medical oncologist and a clinical trialist with expertise in genitourinary tumors. Dr Barata serves as the co-leader of the genitourinary disease team and the Director of Clinical Genitourinary Medical Oncology Research Program at University Hospitals Seidman Cancer Center, Cleveland, Ohio. Dr. Barata's research interests include molecular profiling of tumors and genomic-based therapies for genitourinary tumors.
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Jesse L. Berry, M.D.
Associate Professor of Ophthamology, Director of Ocular Oncology, Vice Chair of Surgery for Academic Affairs, Children's Hospital Los AngelesDr. Berry is Associate Professor Ophthalmology, Director of Ocular Oncology and Vice Chair of Surgery for Academic Affairs Children’s Hospital Los Angeles and the USC Roski Eye Institute. She received her undergraduate and medical degree from Harvard University followed by ophthalmology and fellowship training at USC. Dr. Berry is the founder of Women in Ocular Oncology and Vice President of the International Society of Ocular Oncology. Her clinical expertise focuses on retinoblastoma and uveal melanoma. She holds the A. Linn Murphree, MD Chair in Retinoblastoma and the Berle and Lucy Adams Chair in Cancer Research for her endeavors which include development of the aqueous humor as a liquid biopsy for retinoblastoma which is supported by the National Cancer Institute.
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Scott Bratman, M.D., Ph.D., FRCPC
Associate Professor, University of TorontoDr. Bratman received his MD and PhD from Columbia University in 2009 followed by postdoctoral research and clinical training at Stanford Cancer Institute. Since joining University of Toronto and the Princess Margaret Cancer Centre in 2014, he has served as Staff Radiation Oncologist within the Wharton Head and Neck Centre and has led basic, translational, and clinical research studies on head and neck cancer and circulating biomarkers. Dr. Bratman currently holds the Dr. Mariano Antonio Elia Chair in Head and Neck Cancer Research at University Health Network. The Bratman Lab is taking a bench-to-bedside approach to develop molecular tools for personalized cancer medicine.
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Aadel Chaudhuri, M.D., Ph.D.
Assistant Professor, Department of Radiation Oncology, Washington University in St. LouisDr. Chaudhuri is a physician-scientist and Assistant Professor of Radiation Oncology, Genetics, Biomedical Engineering, and Computer Science at the Washington University in St. Louis. He is also leader of the Liquid Biopsy Working Group at the Washington University Siteman Cancer Center. He additionally serves as Co-Chair of the Liquid Biopsy Interest Group within the National Institutes of Health. Dr. Chaudhuri’s laboratory at Washington University focuses on the development and application of liquid biopsy cancer diagnostic technologies. His laboratory is funded by the National Institutes of Health, the V Foundation, the Cancer Research Foundation, the Children’s Discovery Institute, the Children’s Tumor Foundation, the Alvin Siteman Cancer Research Fund, and the Melanoma Research Alliance.
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Arvind Dasari, M.D.
Associate Professor, Department of Gastrointestinal Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer CenterDr. Dasari is a medical oncologist in the Department of Gastrointestinal Medical Oncology at the University of Texas MD Anderson Cancer Center. His clinical and research efforts are focused on improving outcomes for patients with gastrointestinal cancers. He currently serves as the PI of several trials involving ctDNA including CIRCULATE-US (NCT05174169), MiRDA (NCT04739072) and JANUS (NCT05610163).
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Jennifer Dickey, Ph.D.
Head of Regulatory & Quality, Personal Genome DiagnosticsDr. Dickey is the Head of Regulatory & Quality at Personal Genome Diagnostics (PGDx), now a part of Labcorp Oncology. For this presentation, Dr. Dickey is representing BLOODPAC as one of the scientific co-chairs of the organization. The Blood Profiling Atlas in Cancer (BLOODPAC) Consortium was launched on October 17, 2016, as a commitment to the White House Cancer Moonshot to accelerate the development, validation and clinical use of liquid biopsy assays to better inform medical decisions and improve patient care and outcomes. In February 2017, BLOODPAC became an independent non-profit consortium. Prior to coming to PGDx, Dr. Dickey was a senior reviewer in the Office of In Vitro Diagnostics and Radiological Health (OIR now OHT7) at the Center for Devices and Radiological Health (CDRH), FDA where she led the review of submissions in the Molecular Genetics Branch. Dr. Dickey obtained her Ph.D. from Vanderbilt University and was a post-doctoral fellow at the National Cancer Institute.
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Zeynep Eroglu, M.D.
Medical Oncologist, Department of Cutaneous Oncology, Moffitt Cancer Center, Assistant Professor, Department of Oncologic Sciences, University of South Florida Morsani College of MedicineDr Eroglu is a medical oncologist in the department of Cutaneous Oncology at Moffitt Cancer Center and an associate professor at the University of South Florida. Her clinical focus is on treating patients with advanced melanoma and other skin cancers, including squamous, basal cell and Merkel cell carcinomas, and developing clinical trials. Dr. Eroglu’s research interests are translational and clinical research in targeted therapies and combination immunotherapeutics for melanoma and other skin cancers. She also works to develop personalized treatment strategies and biomarkers for patients with melanoma.
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Doreen Ezeife, M.D., M.Sc., FRCPC
Staff Medical Oncologist, Tom Baker Cancer CentreDr. Doreen Ezeife is a Staff Medical Oncologist at the Tom Baker Cancer Centre in Calgary, Alberta. She treats lung cancer and breast cancer. Doreen’s research focuses on cancer drug access, drug funding and assessing the value of new cancer treatments.
Doreen is the recipient of some prestigious awards for her important research including the American Society of Clinical Oncology Merit Award, Novartis Oncology Young Canadian Investigator Award, Canadian Association of Medical Oncologists’ Fellowship Award, and she has received peer-reviewed grant funding from CIHR, the Alberta Cancer Foundation and Cancer Care Ontario. -
Sarah Greytak, Ph.D.
Scientific Program Analyst, Division of Cancer Treatment and Diagnosis, National Cancer Institute, U.S. National Institutes of HealthDr. Sarah Greytak is a Scientific Program Analyst with the National Cancer Institute’s Biorepositories and Biospecimen Research Branch and has curated for NCI Biospecimen Research Database since 2008. She co-developed the NCI Biospecimen Evidence-Based Practices (BEBP) series and is the lead author on the Cell-Free miRNA: Blood Collection and Processing BEBP, the Cell-Free DNA: Biospecimen Collection and Processing BEBP, and the Nucleic Acid Extraction from Formalin-Fixed, Paraffin-Embedded Tissue BEBP. She earned a bachelor’s degree in Biology (with a minor in Chemistry) from Massachusetts Institute of Technology and a Ph.D. in Biology from Boston University with a specialization in Physiology, Endocrinology, and Reproduction. Dr. Greytak was also a post-doctoral fellow at the Molecular Cardiology Research Institute at Tufts Medical Center.
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Lyndsay Harris, M.D.
Associate Director, Division of Cancer Treatment and Diagnosis, National Cancer Institute, U.S. National Institutes of HealthDr. Lyndsay Harris comes to the NCI from a 30-year career in breast cancer research and translational science. She has over 170 publications and has led Breast Cancer programs at Yale University and Case Western Reserve University where her lab studied the genomics of resistance to HER2 positive breast cancer and disparities in triple negative breast cancer. As Associate Director of the Cancer Diagnosis Program her role is to direct her team in the development of robust prognostic and therapeutic biomarkers through the study of biospecimen science, technology and innovation, pathology evaluation and genomics. The Cancer Diagnosis Program works closely with the Cancer Therapy Evaluation Program (CTEP) to implement biomarkers into several Precision Medicine trials including the NCI-MATCH (Molecular Analysis for Therapy Choice) trial where Dr. Harris serves as a Co-PI and ComboMATCH, a study of novel combination therapies. In addition, Dr. Harris manages the MDNet assay network that has been set up to run molecular assays on three new Precision Medicine trials.
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Chris Karlovich, Ph.D.
Associate Director, Molecular Characterization Laboratory at the Frederick National Laboratory for Cancer ResearchChris Karlovich is Associate Director of the Molecular Characterization (MoCha) Laboratory at the Frederick National Laboratory for Cancer Research (FNLCR). The mission of MoCha is to develop genomic assays in support of research and clinical studies sponsored by the National Cancer Institute. In this capacity, MoCha has played a key role in NCI precision medicine initiatives such as NCI-MATCH, and is currently establishing a network of laboratories in support of the new NCI precision medicine initiatives MyeloMATCH, ComboMATCH and iMATCH. Genomic technologies supported by MoCha include whole exome sequencing, RNA-Seq, single cell genomics, digital spatial profiling and TSO500 ctDNA for liquid biopsies. Prior to coming to FNLCR, Dr. Karlovich was at Clovis Oncology where he provided scientific and operational oversight for molecular diagnostics in several drug development programs. Dr. Karlovich also spent nine years at Roche Molecular Diagnostics in biomarker discovery and in vitro diagnostic (IVD) test development.
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Pashtoon M. Kasi, M.D., M.Sc.
Director Colon Cancer Research; Director Precision Medicine Research for Liquid Biopsies, Weill Cornell MedicineDr. Pashtoon Kasi is an oncologist and researcher at Weill Cornell Medicine and New York-Presbyterian Hospital. He focuses on treating patients with gastrointestinal (GI) cancers and the treatment of patients with novel drugs/early-phase clinical trials. At Weill Cornell Medicine, Dr. Kasi additionally serves as the Director for Colorectal Cancer Research, as well as Precision Medicine Director for Liquid Biopsy Research at the Englander Institute of Precision Medicine. Dr. Kasi’s research focus has been on “liquid biopsies” (circulating tumor DNA (ctDNA) and circulating tumor cells (CTCs)) alongside developing and conducting clinical trials focused on precision oncology and precision medicine. Dr. Kasi is an author and editor of several books including: “Research: What, Why and How: A Treatise from Researchers to Researchers”, and “Impact of circulating tumor DNA (ctDNA) in Patients with Gastrointestinal Malignancies” and has over 100 publications in leading peer-reviewed journals. Additionally, Dr. Kasi has been active as a principal investigator on numerous investigator-initiated, industry-sponsored as well as cooperative group clinical trials in oncology.
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Yanan Kuang, Ph.D.
Blood-based Biomarker Lead, Belfer Center for Applied Cancer Science, Dana Farber Cancer InstituteDr. Kuang’s research focuses on plasma-based biomarker analysis and clinical assay development. Prior to joining the Belfer Center, she was a Scientific Lead and Research Project Manager at Variagenics working on generating modified thermostable polymerase for customized nucleotides and designing a high throughput SNP identification platform. Dr. Kuang received her Ph.D. degree from University of Rochester and did her postdoctoral training at Dana-Farber Cancer Institute.
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Shi-Long Lu, M.D., Ph.D.
Professor, Otolaryngology - Head and Neck Surgery, University of Colorado School of MedicineDr. Lu is a Professor at the Department of Otolaryngology – Head and Neck Surgery and has affiliated appointment at the Departments of Pathology and Dermatology at the University of Colorado Anschutz Medical Campus. Dr. Lu ‘s main research focuses on fundamental and translational aspects of head and neck cancers, including head and neck squamous cell carcinoma (HNSCC) and saliva gland cancers. Specifically, Dr. Lu’s lab works on delineating the roles of signaling transduction, tumor microenvironment, and oral microbiome in HNSCC pathogenesis, establishing mouse models for HNSCC and saliva gland cancer, developing saliva liquid biopsy technology for early detection, recurrence, and surveillance, and exploring novel therapeutic approaches for head and neck cancers.
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Philip C. Mack, Ph.D.
Senior Research Professor and Associated Chair of Center for Thoracic Oncology, Mount Sinai Health SystemDr. Mack conducts molecular biology, molecular pharmacology studies and translational medicine associated with cancer clinical trials, with a focus on lung cancer. He joined the team at the Mount Sinai Tisch Cancer Institute to serve as Associate Director for the Center of Thoracic Oncology, and he also serves as Chair of the Southwest Oncology Group Lung Translational Medicine Committee. Dr. Mack specializes in preclinical modeling of novel cancer therapeutic regimens and clinical trial development, and helped pioneer the concept of detecting circulating tumor DNA in patient plasma as an advanced diagnostic to enable precision medicine in oncology. He has over 140 peer-reviewed publications in oncology. A recent focus has been the intersection between COVID-19 and lung cancer.
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Elizabeth Mansfield, Ph.D.
Vice President of Regulatory Policy, Foundation MedicineElizabeth “Liz” Mansfield serves as the Vice President of Regulatory Policy at Foundation Medicine. She has over 20 years of experience in regulatory affairs, during which she has helped to shape policies and guidance around the regulation of pharmacogenetic tests, companion diagnostics, next generation sequencing assays and direct to consumer genetic tests.
At Foundation Medicine, Dr. Mansfield has helped to secure FDA approval for the company’s liquid biopsy comprehensive genomic profiling test, FoundationOne®Liquid CDx, as well as Breakthrough Device Designation for its tissue-informed circulating tumor DNA monitoring test, FoundationOne®Tracker. She has also overseen more than a dozen companion diagnostic approvals from the FDA for FoundationOne®CDx and FoundationOne®Liquid CDx.
For more than a decade, Dr. Mansfield worked at the FDA on in vitro diagnostics review and policy. Most recently, she served as Associate Office Director for Personalized Medicine in the Office of In Vitro Diagnostics within the FDA’s Center for Devices and Radiological Health where her work emphasized developing policy for FDA oversight of laboratory developed tests.
Dr. Mansfield received her bachelor’s degree in biology from the University of Pennsylvania and her PhD in biochemistry from The Johns Hopkins University. -
Lisa M McShane, Ph.D.
Associate Director, Division of Cancer Treatment and Diagnosis, National Cancer Institute, U.S. National Institutes of HealthDr. McShane heads the Biometric Research Program, comprising Biostatistics and Computational and Systems Biology Branches. She earned a Ph.D. in Statistics from Cornell University and is a Fellow of the American Statistical Association. She is an internationally recognized expert on precision medicine clinical trial design; development of tumor markers and omics predictors for prognosis, therapy selection, and disease monitoring; and reporting guidelines for health research studies. Her statistical research interests include biomarker-driven clinical trial design, analysis of high-dimensional omics data, multiple comparisons methods, surrogate endpoints, and biomarker assay analytical performance assessment. Dr. McShane serves on the Scientific Advisory Board for Science Translational Medicine, and she is a Co-Editor-in-Chief of Statistics in Medicine. She served on American Society of Clinical Oncology committees that developed guidelines for HER2, hormone receptor and other biomarker testing in breast cancer, and EGFR mutation testing in lung cancer. Dr. McShane has coauthored numerous statistical and biomedical papers and book chapters, and she is a frequent speaker at national and international oncology and statistics meetings.
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Alexandra Miller, M.D., Ph.D.
Neurologist & Neuro-Oncologist, Memorial Sloan Kettering Cancer CenterDr. Miller is a Neuro-oncologist at Memorial Sloan Kettering Cancer Center who specializes in the care of patients with primary brain tumors. Her specific interest is in patients with diffuse glioma and she is working toward building a robust translational liquid CSF biopsy program for adults and children with primary brain tumors to better diagnosis, track and monitor the evolution of their disease throughout their illness.
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Muhammed Murtaza, Ph.D., MBBS
Associate Professor, University of Wisconsin School of Medicine and Public HealthDr. Muhammed Murtaza is an Associate Professor within the Department of Surgery and Associate Director of the Center for Human Genomics and Precision Medicine. His research interests include improving access to cutting-edge technology in cancer diagnostics (liquid biopsies) for patients in lower-income settings. The Murtaza Lab is interested in furthering research around circulating and cell-free tumor DNA and RNA. More specifically how it can provide insights into the tumor’s genome thus providing improvements to cancer care.
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Viswam S. Nair, M.D., M.S
Associate Professor, Clinical Research Division, Fred Hutchinson Cancer CenterDr. Nair holds a primary faculty appointment as an Associate Professor in the Clinical Research Division at the Fred Hutchinson Cancer Center. He is clinically trained in pulmonary and critical care medicine with expertise in the diagnosis and management of lung disease in cancer patients. Following clinical training, he studied in the lab of the late Sanjiv “Sam” Gambhir at Stanford University where he developed statistical models and devices for the early detection of lung cancer. His research remains focused on integrating molecular and imaging biomarkers in lung cancer with existing clinical algorithms for more precise detection and treatment. A more recent strategy has been to utilize proximal fluids that are amplified in relevant tumor biomarkers through bronchoscopic sampling of the lung. Within this program, current projects include minimally invasive genomic profiling of cancer and cellular phenotyping of lung cancer during the early and progressive stages of lung cancer.
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Miguel R. Ossandon, Ph.D.
Program Director, Division of Cancer Treatment and Diagnosis, National Cancer Institute, U.S. National Institutes of HealthMiguel R. Ossandon has a dual background in clinical laboratory and computer science. He started working in cancer research at the Lombardi Cancer Center at Georgetown University where he also began his undergraduate training in computer science. He is working for the National Cancer Institute since 2007.
Miguel received his master’s degree at The George Washington University and Ph.D. in computer science at the University of Maryland Baltimore County.
As a Program Director in the Diagnostic Biomarkers and Technology Branch, he manages a grant portfolio related to computational modeling and machine learning approaches for cancer diagnosis, digital image processing/analysis, microfluidic and circulating tumor cell technology. -
Aparna R. Parikh, M.D.
Gastrointestinal Oncologist, Director of the Global Cancer Care Program, Medical Director Young Adult Colorectal Cancer Center, Massachusetts General HospitalDr. Parikh is an expert in Gastrointestinal Cancers with a focus on Young Adults with Colorectal Cancer. Her clinical practice is comprised primarily of patients with colorectal cancer and pancreatic cancer. She is a member of the NCCN guidelines for Colorectal Cancer. She had a robust clinical trial portfolio with the hopes of bringing novel agents into the clinic, working closely with laboratory collaborators at MGH. She also leads the clinical liquid biopsy efforts for the GI Oncology group and is an international expert in liquid biopsies helping to develop these tools in the setting of residual disease after curative intent surgeries, to understand response to treatment as well as to understand drug resistance. Though she is a clinical translational researcher, she also has a passion and background in cancer care in low and middle-incomes countries and does work that supports access, equity and education in LMICs and as the Director of the Global Cancer Care Program at MGH.
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Heather A. Parsons, M.D., M.P.H.
Physician, Susan F. Smith Center for Women's Cancers, Dana-Farber Cancer InstituteDr. Parsons is a Physician at Dana-Farber Cancer Institute, an Associate Physician at the Brigham and Women’s Hospital, and an Assistant Professor of Medicine at Harvard Medical School. She is a clinical translational investigator with a focus on developing novel diagnostics for patients with breast cancer. Dr. Parsons’ specific research interest is in how genomics-based biomarkers and circulating tumor DNA (ctDNA) – tumor-derived DNA found in the plasma – can be used in caring for breast cancer patients. She has led studies in both metastatic and early stage disease investigating the use of ctDNA as a biomarker in breast cancer. Dr. Parsons’ research is supported by the NCI, by the Susan G. Komen Foundation and the Gateway Foundation for Cancer Research. Her work has previously been supported by The Bridge Program of MIT and Dana-Farber/Harvard Cancer Center; the DF/HCC Breast Cancer SPORE grant; the Terri Brodeur Foundation and as part of projects funded by the Breast Cancer Research Foundation. She is the recipient of a Conquer Cancer Foundation Young Investigator Award.
Dr. Parsons is a graduate of Dartmouth College and has a Master of Public Health from Johns Hopkins Bloomberg School of Public Health. She received her medical degree from Drexel University College of Medicine, where she was inducted into the AOA Honor Medical Society. She was then an Osler Medicine resident in Internal Medicine at The Johns Hopkins Hospital. She completed a fellowship in Medical Oncology at Johns Hopkins Hospital before joining the Susan F. Smith Center for Women’s Cancers at Dana-Farber Cancer Institute. -
Abhijit Patel, M.D., Ph.D.
Associate Professor of Therapeutic Radiology, Yale School of MedicineAbhijit Patel’s group at Yale University is focused on developing and validating liquid biopsy technologies for early cancer detection and surveillance of residual or recurrent disease. The Patel group has recently developed a pan-cancer assay that can detect aberrant gene silencing patterns through untargeted capture of hypermethylated promoter sequences in cell-free DNA. Dr. Patel is an Associate Professor of Therapeutic Radiology at the Yale University School of Medicine. He completed residency training in radiation oncology at Harvard University, medical internship at Memorial Sloan-Kettering Cancer Center, and obtained his MD and PhD degrees at Yale University. His scientific background is in the field of nucleic acid biochemistry, having completed his Ph.D. and postdoctoral training with Drs. Joan Steitz and Jack Szostak. As a physician-scientist, he also maintains an active clinical radiation oncology practice.
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Sameek Roychowdhury, M.D., Ph.D.
Associate Professor, The James Cancer Hospital and Comprehensive Cancer Center, Department of Internal Medicine and Division of Medical Oncology, The Ohio State UniversitySameek Roychowdhury is a graduate of The Ohio State University, B.S. Molecular Genetics 98’, Immunology Ph.D. 04’, and M.D. 06’. Dr. Roychowdhury is Associate Professor of Medical Oncology at the Comprehensive Cancer Center and the James Cancer Hospital at the Ohio State University. He leads a multi-disciplinary precision cancer medicine team combining expertise in genomics, computer science, novel diagnostics, biology, and clinical trials to deliver precision cancer medicine to patients. Dr. Roychowdhury is Medical Director of a clinical grade Cancer Genomics Lab and leads precision medicine trials called “basket” studies that focus on genetic markers rather than type of cancer. The team’s research has been funded by the National Cancer Institute, the American Cancer Society, the Prostate Cancer Foundation, and the American Lung Association. Together this team focuses on:
- Developing novel tests for patients with cancer
- Developing clinical trials that offer novel therapies for patients based on markers in their cancer
- Drug development for genomic alterations involving Fibroblast Growth Factor Receptor and Microsatellite Instability
- Seeing patients each week in a Precision Cancer Medicine clinic to evaluate patients for novel markers and clinical trials
- Collaborating with patients and families for a study on body donation for cancer research through research autopsy
- Developing telehealth enabled clinical trials for precision oncology
- Training the next generation of scientists
For more information about the team and research please visit: http://www.precisioncancermedicine.osu.edu/ -
Katja Schulze, Ph.D.
Director Oncology Biomarker Development & Medical Affairs, Genentech, Inc.Katja Schulze works as Director Oncology Biomarker Development and Medical Affairs at Genentech, located in South San Francisco. In this role she leads translational science efforts in oncology and is enabling precision medicine by investigating and implementing novel biomarker testing into clinical practice in the US. She conducts biomarker research in collaboration with non-industry experts that informs innovative trial designs, studies predictive and prognostic biomarkers, as well as resistance mechanisms. Her work also includes research in disease monitoring as well as investigating early biomarker-based clinical trial endpoints. Her focus is on thoracic malignancies and she also leads pan-tumor biomarker research such as the MyPathway study. Katja has joined Roche/Genentech in 2011, working in various positions within research and development.
Katja holds a PhD in molecular and cellular biology from the University of Berne and a DVM from the Ludwig Maximilian University of Munich, Germany. -
Brian Sorg, Ph.D., MBA
Branch Chief, Division of Cancer Treatment and Diagnosis, National Cancer Institute, U.S. National Institutes of HealthBrian Sorg obtained his B.S. degree in electrical engineering from the University of Maryland, M.S. degree in biomedical engineering from Johns Hopkins University, and Ph.D. in biomedical engineering from the University of Texas at Austin. He did post-doctoral training in tumor biology at Duke University Medical Center in the Department of Radiation Oncology. As an Assistant Professor in the Department of Biomedical Engineering at the University of Florida, his research focused on in vivo spectral imaging microscopy of tumor microvasculature to measure oxygen delivery effects of anti-vascular targeting therapies. Brian’s current research interests and NCI grant portfolio are focused on technology development for biosensors and various cellular and molecular separation and analysis techniques for biomarker discovery and clinical application. His portfolio and research interests also include liquid biopsies, microfluidics, tissue chips, in vitro optical imaging, and other biophotonics technologies for applications in cancer diagnosis and treatment. While at NCI, Brian obtained an MBA from the Kenan-Flagler Business School of the University of North Carolina at Chapel Hill.
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Patty Spears, B.S.
Research Patient Advocate, UNC Lineberger Cancer CenterMs. Spears is a cancer research patient advocate bringing the experience as an over 20-year breast cancer and recent liver cancer survivor. She has participated in two clinical trials including a HER2 vaccine clinical trial. She is currently working as a patient advocate at the University of North Carolina (UNC) at Chapel Hill, Lineberger Comprehensive Cancer Center (LCCC) where she leads the UNC Lineberger Patient Advocates for Research Council (PARC) and the UNC Breast SPORE Advocates. At UNC she focuses on communicating research to the public and facilitates the engagement of patient advocates with Lineberger researchers. Ms. Spears has been an advocate for the National Clinical Trials Network (NCTN) since 2008, and is currently the Associate Group Chair for Advocacy for the Alliance for Clinical Trials in Oncology and Chair of the Alliance Patient Advocate Committee. She is also a member of NCI’s Clinical Trials and Translational Research Advisory Committee (CTAC), Investigational Drug Steering Committee (IDSC), and is currently Co-Chair of the Patient Advocate Steering Committee (PASC). She has also formerly served on the Core Correlative Science Committee (CCSC) and the Breast Cancer Steering Committee (BCSC). Ms. Spears has also been a volunteer for several national cancer organizations including the American Society of Clinical Oncology (ASCO) and American Association for Cancer Research (AACR). She is the recipient of the AACR 2020 Distinguished Public Service Award for Advocacy and the ASCO 2022 Patient Advocate Award. She has a long-standing commitment to clinical research and is on a study team looking at using ctDNA as a biomarker in late recurrence breast cancer.
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Ying-Hsiu Su, Ph.D.
Professor, Baruch S. Blumberg InstituteDr. Su is a Professor in The Baruch S Blumberg Institute, with a research focus on hepatocellular carcinoma (HCC) and hepatitis B virus (HBV). She holds a Bachelor of Science degree in Biology from National Taiwan Normal University (1983) and a Ph.D. in Microbiology/Immunology from the University of South Alabama (1992).
Dr. Su’s team has made pioneering contributions to the detection of circulation-derived tumor DNA in urine, offering a non-invasive approach to tumor screening and providing insights into cancer genetics upon detection. Dr. Su is an associate member of the Early Detection Research Network at the National Cancer Institute (NCI). Her research has focused on developing methods to preferentially isolate short, fragmented DNA in urine and innovative assays to detect low-abundance cell-free DNA sequences of interest. These advancements enable the development of a urine test for HCC screening, detection of minimal residual disease (MRD), and facilitate monitoring for recurrence after cancer treatment.
In the field of HBV-related research, Dr. Su’s team has focused on understanding the role of integrated HBV DNA in carcinogenesis. Her team developed the ChimericSeq computational tool, which robustly detects HBV viral-host junction sequences. Additionally, Dr. Su’s team has developed a highly sensitive HBV-targeted NGS assay capable of detecting HBV viral-host junction DNA in urine and plasma. This work has shown the promise of utilizing HBV viral-host junction DNA in urine as a biomarker for HCC MRD assessment, monitoring treatment response, and recurrence. -
Laura van 't Veer, Ph.D.
Professor, Laboratory Medicine and Director, Applied Genomics, Helen Diller Family Comprehensive Cancer Center, University of California San FranciscoDr. Laura van ‘t Veer is a world-renowned molecular biologist whose research focuses on precision medicine to advance patient management. She is co-leader of the Breast Oncology Program at the University of California San Francisco, USA. She co-founded in 2003 the biotech company Agendia (Amsterdam and Irvine, CA USA), a spin-off of the Netherlands Cancer Institute. From 1991-2010 she was employed at the Netherlands Cancer Institute-Antoni van Leeuwenhoek Ziekenhuis, Amsterdam, where she instigated the Department of Molecular Pathology (1993), the Hereditary Cancer Clinic (1994), and was Division Leader Diagnostic Oncology (2007-2010). As co-inventor of MammaPrint, FDA 510K cleared since 2008, she has made a seminal impact on “rightsizing” the treatment of breast cancer, especially to indicate that a large proportion of patients can consider foregoing chemotherapy when the tumor is MammaPrint low risk. Dr. van ‘t Veer is currently in the US co-PI of the multicenter adaptive clinical trial I-SPY2 overseeing FDA-IDE ‘Response-Predictive-Subtyping’ companion diagnostics. This neo-adjuvant trial explores ctDNA assessment as an early surrogate endpoint to monitor treatment response. Further, she leads the molecular risk assessment of the 55,000 women WISDOM study (Women Informed to Screen Dependent on Measures of Risk). She has over 320 peer-reviewed scientific articles and is a co-inventor of 10 patents. Dr. van 't Veer received many awards, among which the prestigious European Union Women Innovator Award, 2nd prize in 2014, the 2015 European Patent Office Inventor Award, is a 2020 PMWC Luminary Award recipient, and a 2020 Giants of Cancer Care awardee.
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Yuxuan Wang, M.D., Ph.D.
Assistant Professor, Gastrointestinal Cancer Program, Johns Hopkins Sidney Kimmel Comprehensive Cancer CenterDr. Wang is an assistant professor in the Gastrointestinal Cancer Program at the Johns Hopkins Sidney Kimmel Comprehensive Cancer Center. She obtained her M.D. and Ph.D. degrees from Johns Hopkins School of Medicine, and subsequently completed internal medicine residency and medical oncology fellowship at Johns Hopkins Hospital. She trained under Bert Vogelstein and Kenneth Kinzler, and has developed various sequencing-based assays for the non-invasive detection of common cancers. Her current focus is on developing effective cancer detection methods to improve patient outcome.
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David. T. W. Wong, D.M.D., D.M.Sc.
Professor, Director, University of California, Los Angeles Center for Oral/Head & Neck Oncology ResearchDr. Wong is Professor and Director of the Oral/Head and Neck Oncology Research Center at UCLA. He is a Fellow of the American Association for the Advancement of Sciences (AAAS), Fellow of AADR, past member of the ADA Council of Scientific Affairs, and the past president of American Association of Dental Research (AADR). He is the current chair of the NCI Liquid Biopsy Consortium and chartered member and chair of the NIH CSR Molecular Cancer Diagnostics and Classification (MCDC) study section.
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Joshua Xu, Ph.D.
Supervisory Computer Scientist, Division of Bioinformatics and Biostatistics, National Center for Toxicological Research, U.S. Food & Drug AdministrationDr. Joshua Xu received his Ph.D. degree in electrical engineering from Texas A&M University with research in medical image analysis. He is the Branch Chief for Research-to-Review and Return (R2R) at the Division of Bioinformatics and Biostatistics of FDA's National Center for Toxicological Research (NCTR). He is an expert in next-generation sequencing (NGS) data analysis, image analysis, artificial intelligence, and informatics system development. His recent focus has been with the FDA-led Sequencing Quality Control Phase 2 (SEQC2) project to evaluate the technical reliabilities and scientific applications of the next generation sequencing (NGS) technologies. He led the SEQC2 Oncopanel Sequencing Working Group to assess the reproducibility and detection sensitivity of oncology panel sequencing including liquid biopsy tests that analyze circulating tumor DNA in blood to advance precision medicine. The Working Group consisted of over 200 participants from academia, government agencies, and industry including 8 companies providing onco-panels and 30 testing laboratories. He is also the Executive Secretary for the international Massive Analysis and Quality Control (MAQC) society.